Effect of the SIMS Programme on Preschool Children's Oral Hygiene Level

NCT04339647 | Completed

• 1 other identifier: IIRG035A
• Study Type: interventional
• Target: 653
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cluster randomised control trial targeting 5-6-year-old children and their parents in Kampar district, Perak, Malaysia for a period of 6 months. In total, 28 preschools are randomly assigned into intervention and control group (14 preschools per group). Sample size for each group is 317 children. The intervention group receives the SIMS programme (SIMSP) which is an improved version of the usual care, while the control group receives the usual care. Usual care in defined as the existing preschool oral health programme (POHP) offered by the Ministry of Health. The SIMSP is formulated based on the recommendations from the National Oral Health Survey of Preschool Children's (2015) report. It comprises active participation of dental therapists (DT), parents and class teachers in children's oral health. The concept of the SIMSP is that improvement in oral health behaviours and oral hygiene of preschool children would result in improvement of gingival health and caries level in their permanent teeth in the long term. On the other hand, the control group involves DT visiting preschools twice a year without parental nor teachers active involvement. The scientific hypothesis of the study is that the SIMSP is more effective to improve oral hygiene level of preschool children than the POHP over 6 months. The primary objective of the study is to assess the effect of the SIMSP versus the POHP in improving oral hygiene level among 5-6-year-old children over 6 months. The secondary objectives are to assess the changes in oral health behaviours among the children and oral health literacy among parents over 6 months.

Conditions

Dental Plaque

Keywords

Preschool; Children; Dental plaque; Oral health behaviour; Health literacy

Outcome Measures

Primary Outcomes (1)

• The mean decrement in plaque score assessed using the Oral Cleanliness Index

  The mean decrement in plaque score from baseline to follow up between the intervention and control group will be assessed. Assessment for the presence of visible plaque will involve examining the labial surfaces of upper right to upper left primary canines. Each of the surface is assessed by scoring; 0 = teeth appear clean, 1 = a little plaque visible (existence of plaque around the labial cervical margins and covering \< ½ of labial tooth surfaces), 2 = substantial amount of plaque visible (plaque covering \> ½ labial tooth surfaces), and 9 = assessment cannot be made (there is no teeth in both anterior segments for plaque assessment). Total score is the sum of scores from the 6 surfaces. Mean decrement score is obtained by subtracting mean score at follow up from mean score at baseline. Finally, mean decrement scores of intervention and control group are compared.

  6 months

Secondary Outcomes (2)

• Changes in child's oral health behaviours assessed using a self-reported questionnaire by parents

  6 months

• The mean increment of oral health literacy score of parents/guardians assessed using The Dental Health Literacy Assessment Index (DHLAI)

  6 months

Study Arms (2)

The SIMS Programme

EXPERIMENTAL

The SIMS programme is a community-based intervention which improvised the usual care (defined as the existing preschool oral health programme) offered by the Ministry of Health. The target group is 5-6-year-old preschool children and their parents. Apart from the usual care, the 5-6-year-old children receive interventions carried out by teacher in school and home tooth brushing supervision by parents. In addition, parents/guardians will receive OHE from the DT team, free toothbrush and toothpaste (1000ppm F) for child home tooth brushing and supervised child home tooth brushing for 6 months.

Behavioral: The SIMS programme

Control

NO INTERVENTION

The control group receives the usual care from the preschool oral health programme. The usual care is described as a DT team visiting the school to do an oral examination, provides OHE to the children, and applies fluoride varnish (20,000 ppmF) twice/year.

Interventions

The SIMS programme BEHAVIORAL

The intervention targets 5-6-year-old preschool children and their parents. Apart from the usual care, 5-6-year-old children receive oral health lessons and supervised daily tooth brushing (1000ppm F) at school over a period of 6 months, as well as home tooth brushing supervision by parents for 6 months. Parents/guardians attend a meeting with a DT team at school to discuss on child's oral health status, receive OHE and free toothbrush and fluoride toothpaste (1000ppm F) for child home tooth brushing, and receive 10 oral health infographic messages from DT over a period of 5 months (with printed versions available).

The SIMS Programme

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are healthy
• Preschool children who can understand Malay language
• Parents who can speak and write in Malay language

You may not qualify if:

• Children with chronic medical conditions, dental/oral developmental conditions, long term medications, and physical disability

Sponsors & Collaborators

• University of Malaya: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

State Education Department

Ipoh, Perak, 30640, Malaysia

Location

Related Publications (16)

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  BACKGROUND

• Gao X, Lo EC, McGrath C, Ho SM. Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial. Trials. 2013 Apr 30;14:118. doi: 10.1186/1745-6215-14-118.

  PMID: 23782918 BACKGROUND

• Guse K, Levine D, Martins S, Lira A, Gaarde J, Westmorland W, Gilliam M. Interventions using new digital media to improve adolescent sexual health: a systematic review. J Adolesc Health. 2012 Dec;51(6):535-43. doi: 10.1016/j.jadohealth.2012.03.014. Epub 2012 May 5.

  PMID: 23174462 BACKGROUND

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  PMID: 12535435 BACKGROUND

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  PMID: 12723835 BACKGROUND

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  BACKGROUND

• Rajab LD, Petersen PE, Bakaeen G, Hamdan MA. Oral health behaviour of schoolchildren and parents in Jordan. Int J Paediatr Dent. 2002 May;12(3):168-76. doi: 10.1046/j.1365-263x.2002.00359.x.

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  PMID: 11683551 BACKGROUND

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  PMID: 31338357 BACKGROUND

• Pitts NB, Ekstrand KR; ICDAS Foundation. International Caries Detection and Assessment System (ICDAS) and its International Caries Classification and Management System (ICCMS) - methods for staging of the caries process and enabling dentists to manage caries. Community Dent Oral Epidemiol. 2013 Feb;41(1):e41-52. doi: 10.1111/cdoe.12025.

  PMID: 24916677 BACKGROUND

• . Ludke RL, Kudel I, and Weber DL, Dental Health Literacy Assessment Instrument, U.o. Cincinnati, Editor. 2008.

  BACKGROUND

• Yusof ZYM, Anwar NH, Mohd Nor NA, Nor MM, Mustafa SE. The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial. Trials. 2021 Feb 22;22(1):156. doi: 10.1186/s13063-021-05111-0.

  PMID: 33618735 DERIVED

Related Links

• National Oral Health Survey of Preschool Children, Malaysia, 2015

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Zamros YM Yusof, BDS, MSc, PhD

  Faculty of Dentistry, University of Malaya, Kuala Lumpur, 50603, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomised Controlled Trial

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 9, 2020
• Study Start: February 18, 2019
• Primary Completion: October 17, 2019
• Study Completion: November 17, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)